Abstract

Background: Biosimilars can be considered generic versions of branded biologic medicines. Substituting branded biologic medicines with biosimilars is important to reduce medication costs. In addition to reducing drug costs, the domestic production of biosimilars can provide many other economic benefits. Therefore, this study aimed to investigate the economic benefits of producing biosimilar medicines in Iran.
 Methods: This study was done in 2021 through 2 qualitative and quantitative steps. In the first step, after literature review, the interview guide was designed and semi-structured interviews with experts continued until reaching the saturation point, after interviewing 9 experts from different fields (imports, production, and policy making). The data were coded and analyzed by thematic analysis using MaxQDA software and the economic benefits of producing the biosimilars in Iran were extracted. In the quantitative step, the price advantage of producing domestic biosimilars was analyzed as one of their most important economic advantages compared to its equivalent in reference countries. In addition, the same comparison was done for the main imported branded medicines.
 Results: From the experts’ viewpoints, the most important economic effect of the domestic production of biosimilars was the reduction of medication costs through access to lower-priced medicines. The employment of professionals, development of new technologies, expansion of the pharmaceutical market, the reduction of foreign currency outflows, increased affordability and access to drugs, and ultimately the improvement of the health level of the society were the other economic aspects of these medicines. In the quantitative step, after comparing the prices of 23 domestic biosimilars with the prices of the equivalent medicines in reference countries, the prices of 21 medicines were lower than the average prices of equivalent biosimilars and the prices of 18 medicines were even lower than the minimum price of the equivalent biosimilars in the reference countries. In addition, the production of these drugs in the country is indirectly effective in reducing the price of the main branded drugs in the country, so that in the case of imported branded biologic medicines, out of 28 medicines, the prices of 26 medicines were lower than the average prices in the reference countries and the prices of 23 medicines were even lower than the minimum of prices in the reference countries. 
 Conclusion: Based on the results of the study, it was concluded that the domestic production of biosimilar medicines in Iran, in addition to increasing access to biological drugs and promoting public health, provides many economic benefits, including saving drug costs.

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